NCT04173052

Brief Summary

Background : Up to 15 percent of couples are infertile. In up to half of these couples, male infertility plays a role. Male infertility is due to low sperm production, abnormal sperm function or blockages that prevent the delivery of sperm. Illnesses, injuries, chronic health problems, lifestyle choices and other factors can play a role in causing male infertility. Methodology : It is an interventional trial that involved 45 participants with infertility (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia). All the participants underwent a semen analysis for his semen count, volume and motility for a sample taken by masturbation. Then I gave each one of the participants a small device. This device gives an electrical shock up to 5 milliamps. I told each one independently to use this device properly on his testis every day and come for follow up checking every month. After the fourth months, I made the final checkup for everyone and records my data and make a comparison between (before and after) semen analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

November 18, 2019

Last Update Submit

November 20, 2019

Conditions

Keywords

InfertilityElectrical shocksperms activationSemen Analysis

Outcome Measures

Primary Outcomes (2)

  • Sperms movement

    Monitoring the changes that could occur in the motility of the sperms for each participant and record that.

    3 months

  • Sperms' number

    Monitoring the changes that could occur in the numbers of the sperms for each participant and record that.

    3 months

Study Arms (1)

Infertile Males

EXPERIMENTAL

It represents the participants, all the participants in the study are infertile.

Device: Testis' shocker

Interventions

The device gives electrical shock ranged (1-5) milliAmpere designed to fit the testis shape for the males.

Also known as: JT®
Infertile Males

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males with (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia)

You may not qualify if:

  • Males with (Aspermia or Azoospermia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al- Nassiryah Laboratory's

Baghdad, 60001, Iraq

Location

Related Publications (1)

  • Hashim HT, Varney J, Qais Z, Reda A, Qaderi S, Chowdhury NS, Murry K, Shah J, Alhaideri A, Ahmad S, Hashim AT, Rehman R, Ahmed N, Al-Jorani MS, Skuk M, Abdalhusain M, Khalafalla K. Direct and Gradual Electrical Testicular Shocks Stimulate Spermatogenesis and Activate Sperms in Infertile Men: A Randomized Controlled Trial. Am J Mens Health. 2024 Nov-Dec;18(6):15579883241296881. doi: 10.1177/15579883241296881.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Hashim T Hashim, MD

    University of Baghdad / College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 21, 2019

Study Start

June 1, 2019

Primary Completion

September 20, 2019

Study Completion

September 25, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations